Formulation development is fraught with challenges such as: 1. Stability: Ensuring that the API remains stable and effective over the product's shelf life. 2. Solubility: Enhancing the solubility of poorly water-soluble drugs. 3. Bioavailability: Maximizing the amount of API that reaches the systemic circulation. 4. Compatibility: Ensuring that excipients do not interact negatively with the API. 5. Patient Acceptability: Creating a formulation that is acceptable and easy to use for patients.